The Human Medicines Regulations 2012

Recording, reporting and assessment of pharmacovigilance data U.K.

Recording obligations on the licensing authority U.K.

185.  The licensing authority must record all suspected adverse reactions to medicinal products that—

(a) occur in the United Kingdom; and

(b) are reported to it by [F1 a holder,] a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.

Textual Amendments

F1 Words in reg. 185(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 144; 2020 c. 1, Sch. 5 para. 1(1)

Reporting obligations on the licensing authority U.K.

186.—(1) The licensing authority must—

(a) when it receives a suspected adverse reaction report from a person mentioned in regulation 185(b), follow up the report with that person as appropriate;

(b) ensure that reports of suspected adverse reactions in the United Kingdom may be submitted to it, whether by the UK web-portal or by other means;

(c) collaborate with the EMA and the holders of authorisations or registrations in the detection of duplicates of suspected adverse reaction reports;

[F2 (d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.]

(2) Paragraph (3) applies where the licensing authority has received a report of a suspected adverse reaction arising from an error associated with the use of a medicinal product.

(3) The licensing authority must (in addition to meeting the requirements in paragraph (1) in respect of the report) ensure that the report is made available to any statutory body with functions in relation to patient safety within the United Kingdom.

F3 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Reg. 186(1)(d)(e) substituted (31.12.2020) by S.I. 2019/775, reg. 145(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 113)

F3 Reg. 186(4) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 145(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 113)

[F4 186A.   The licensing authority must collaborate with the World Health Organisation in matters of pharmacovigilance, and must in particular—

(a) take the necessary steps to promptly submit to the World Health Organisation appropriate and adequate information regarding the measures taken in the United Kingdom which may have a bearing on public health protection in other countries; and

(b) make available promptly all suspected adverse reaction reports occurring in the United Kingdom to the World Health Organisation.]

Textual Amendments

F4 Reg. 186A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 146; 2020 c. 1, Sch. 5 para. 1(1)

Recording obligations on holders U.K.

187.—(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product [F5 (including listed NIMAR products in Northern Ireland)] occurring [F6 in the United Kingdom or another country] which are brought to its attention irrespective of whether the reaction—

(a) is reported spontaneously by patients or health care professionals; or

(b) occurred in the context of a post-authorisation study.

(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.

(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the [F7 United Kingdom].

Textual Amendments

F5 Words in reg. 187(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 15

F6 Words in reg. 187(1) substituted (31.12.2020) by S.I. 2019/775, reg. 147(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 114)

F7 Words in reg. 187(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 147(3); 2020 c. 1, Sch. 5 para. 1(1)

Reporting obligations on holders U.K.

188.—(1)  [F8 The holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation] must in relation to the product [F9 (including listed NIMAR products in Northern Ireland)]—

(a) submit electronically to the [F10 licensing authority] a report on all serious suspected adverse reactions that occur in the [F11 United Kingdom] and [F12 countries other than the United Kingdom] before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the [F10 licensing authority] a report on all non-serious suspected adverse reactions that occur in the [F13 United Kingdom] before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(c) establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(d) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the [F10 licensing authority] by way of an update to the original report within the specified time period; and

(e) collaborate with the [F14 licensing authority] in the detection of duplicates of suspected adverse reaction reports.

[F15 (1A) The holder of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a) submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day on which the holder gained knowledge of the reaction;

(c) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and

(d) collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.]

(2) The holder [F16 of a UKMA(NI), a UKMA(UK), a THR(NI), a THR(UK) or an Article 126a authorisation] is not required to submit a report of a suspected adverse reaction to the product under [F17 paragraph (1A)(a) or (b)], or to provide follow-up information under [F18 paragraph (1A)(c)], where—

(a) the suspected adverse reaction relates to a medicinal product which contains a monitored active substance; and

(b) the suspected adverse reaction is recorded in a monitored publication.

(3) [F19 Paragraph (4A)] applies to medicinal products containing a monitored active substance.

(4) The holder must—

(a) monitor medical literature F20 ... for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1).

[F21 (4A) The holder of a UKMA(NI), a UKMA(UK), a THR(NI), a THR(UK) or an Article 126a authorisation must—

(a) monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).]

(5) In this regulation—

F22 ...

F22 ...

“the specified time period” means—

(a)

in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; and

(b)

in the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.

F23 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F8 Words in reg. 188(1) substituted (31.12.2020) by S.I. 2019/775, reg. 148(3)(za) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(a))

F9 Words in reg. 188(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 16

F10 Words in reg. 188 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(2); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in reg. 188(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in reg. 188(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in reg. 188(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in reg. 188(1)(e) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

F15 Reg. 188(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 148(3A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(b))

F16 Words in reg. 188(2) inserted (31.12.2020) by S.I. 2019/775, reg. 148(4)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))

F17 Words in reg. 188(2) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))

F18 Words in reg. 188(2) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))

F19 Words in reg. 188(3) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4A) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))

F20 Words in reg. 188(4)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(5); 2020 c. 1, Sch. 5 para. 1(1)

F21 Reg. 188(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 148(5A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(d))

F22 Words in reg. 188(5) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(6); 2020 c. 1, Sch. 5 para. 1(1)

F23 Reg. 188(6) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(7); 2020 c. 1, Sch. 5 para. 1(1)